Single Patient Modification Requests
A Single Patient Modification Request is used when an investigator needs IRB approval to make a change to an approved research protocol that applies to one participant only. This process allows investigators to request an exception or modification for an individual participant while maintaining appropriate oversight and participant protections.
A Single Patient Modification Request is used when an investigator needs IRB approval to make a change to an approved research protocol that applies to one participant only. This process allows investigators to request an exception or modification for an individual participant while maintaining appropriate oversight and participant protections.
A Single Patient Modification Request is different from a Single Patient Expanded Access submission, which is a separate FDA-regulated pathway for access to investigational products outside of a clinical trial.
When Should a Single Patient Modification Request Be Used?
A Single Patient Modification Request may be appropriate when a change is needed for one participant that is not permitted under the currently approved protocol.
Examples include:
- Allowing enrollment of a participant who does not meet all eligibility criteria
- Modifying the schedule or timing of study visits or procedures
- Adjusting investigational product dosing or administration for an individual participant
- Modifying study procedures or assessments for one participant
- Making participant-specific changes to the consent process or consent document
These requests should be used only in limited circumstances and only when there is a clear scientific, medical, or ethical justification for the proposed change.
Important Requirements
You must obtain IRB approval before implementing the proposed change.
Investigators may not prospectively deviate from an IRB-approved protocol without prior IRB approval unless necessary to eliminate an immediate hazard to a participant.
When reviewing a Single Patient Modification Request, the IRB will consider:
- The rationale for the proposed change
- Whether participant safety is adequately protected
- Whether the modification remains consistent with the scientific and ethical goals of the study
- Whether additional safeguards or changes to the consent process are needed
The IRB Chair or designee will determine whether the request qualifies for expedited review or requires review by the convened IRB.
What to Submit
To request a participant-specific modification:
- Locate the Single Patient Modification Request Form (SPMRF) in PROTECT.
- Complete all required fields on the form.
- Submit the completed SPMRF as an attachment to a Modification (MOD) submission in PROTECT.
- Include as supporting documentation, such as:
- Revised consent documents
- Sponsor correspondence or approvals
- Medical justification
- Other documents supporting the request
Example
A participant does not meet all protocol eligibility criteria, but the investigator believes enrollment is appropriate based on the participant's clinical circumstances.
In this situation, the investigator may submit a Single Patient Modification Request describing:
- The specific eligibility criterion that is not met
- The scientific or medical justification for the exception
- Any additional risks and how they will be managed
- Why the proposed change remains consistent with the objectives of the study
The participant may not be enrolled until IRB approval is obtained.
Need Help?
If you are considering a Single Patient Modification Request and are unsure whether this process is appropriate, contact the NIH Office of IRB Operations at irb@od.nih.gov before submitting your request.